SANDIMMUN

This brand name is authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug SANDIMMUN contains one active pharmaceutical ingredient (API):

1
UNII 83HN0GTJ6D - CYCLOSPORINE
 

Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.

 
Read more about Ciclosporin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SANDIMMUN Concentrate for solution for infusion MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L04AD01 Ciclosporin L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AD Calcineurin inhibitors
Discover more medicines within L04AD01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 5631J, 6109M
BR Câmara de Regulação do Mercado de Medicamentos 526513301157311, 526513302153318, 526513402115310, 526513403138314, 526513404118317, 526513405114315
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00042777, 00042783, 00165385, 00165391, 00165416, 00165422, 00165439, 00165445, 00424645, 00424668, 01593692, 01688613, 01688814, 01688843, 01895223, 01895246, 02560430, 03633148, 03633154, 04289233, 04680210, 04680227, 04680233, 04680256, 04781135, 04781141, 04781158, 04781164, 04964025, 04994670, 04994687, 04994693, 05392364, 05392370, 05392387, 05392393, 05392401, 05392418, 07669686, 08760064, 08763890, 08763909, 08763915, 08763921, 08763938, 08763944, 08775746, 08816304, 08816310, 08816327, 08816333, 08816356, 08816362, 08898874, 08898880, 08898897, 08898905, 09282419, 12638104, 16774761, 17448288, 17448294, 17848668, 17848674
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 20.241-1-08-02, 20.243-1-08-02
EE Ravimiamet 1008526, 1008548, 1008559, 1235135, 1693548, 1731855, 1787474, 1865279
ES Centro de información online de medicamentos de la AEMPS 56798, 56799, 56800, 60318, 60319, 60320
FI Lääkealan turvallisuus- ja kehittämiskeskus 061937, 466482, 467563, 467720, 586107
FR Base de données publique des médicaments 62935801
GB Medicines & Healthcare Products Regulatory Agency 23546, 23548, 23550, 27800, 27804, 34908
HK Department of Health Drug Office 20029, 38058, 38059, 38060, 38061, 51354
HR Agencija za lijekove i medicinske proizvode HR-H-141846183, HR-H-144486729, HR-H-547220134, HR-H-725462434, HR-H-861000959
IE Health Products Regulatory Authority 88165, 88166, 88167, 88168, 88169
IL מִשְׂרַד הַבְּרִיאוּת 3005, 3006, 3007, 3008
IT Agenzia del Farmaco 029453014, 029453026, 029453038, 029453053
JP 医薬品医療機器総合機構 3999004S1036, 3999406A1032
LT Valstybinė vaistų kontrolės tarnyba 1001739, 1001740, 1001741, 1090664, 1090665
MT Medicines Authority AA565/46501, MA1249/02701, MA1249/02702, MA1249/02703
MX Comisión Federal para la Protección contra Riesgos Sanitarios 099M84, 106M84, 223M90
NG Registered Drug Product Database 04-9672
Switch country to Nigeria in order to find specific presentations of SANDIMMUN
NZ Medicines and Medical Devices Safety Authority 3909, 3910, 3911, 3912, 3913, 3914
PL Rejestru Produktów Leczniczych 100059881, 100059898, 100059906, 100059912, 100085223, 100247000
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W01231001, W51398001, W51399001
SG Health Sciences Authority 00520P, 08176P, 08177P, 08178P, 08179P, 09871P
TN Direction de la Pharmacie et du Médicament 10283111H, 10283112H, 10283151H, 10283261H, 10283262H, 10283263H
TR İlaç ve Tıbbi Cihaz Kurumu 8699504190007, 8699504190052, 8699504590005, 8699504760057
ZA Health Products Regulatory Authority 29/34/0056, 29/34/0058, 29/34/0059, 35/34/0132, Q/34/271, R/34/267

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